Orgenesis, Inc. (NASDAQ: ORGS) is a clinical-stage biotechnology company focused on advancing cell and gene therapies through its decentralized manufacturing model. Founded in 2011 as a spin-out from the Mount Sinai Health System, Orgenesis offers a comprehensive suite of technologies, services and intellectual property designed to enable point-of-care production of personalized therapeutics. The company’s portfolio encompasses process development, automated manufacturing platforms and quality management systems that support the entire life cycle of cell and gene therapy products.
Central to Orgenesis’ strategy is the CellGYM™ platform, which integrates modular manufacturing devices with proprietary software to facilitate on-site production of autologous and allogeneic treatments. This platform is complemented by a network of development and training facilities, where Orgenesis works closely with academic medical centers, contract development and manufacturing organizations (CDMOs), and pharmaceutical companies to transfer know-how and implement scalable workflows. By localizing manufacturing, Orgenesis seeks to reduce production times, lower costs and improve patient access to advanced therapies.
The company’s services extend from early-stage process optimization and analytical testing to full-scale commercialization support, regulatory compliance assistance and tech transfer. Orgenesis has established partnerships across North America, Europe and Asia, supporting programs in oncology, neurology, rare diseases and regenerative medicine. Through these collaborations, Orgenesis has helped clients advance multiple clinical-stage candidates toward regulatory filing and market launch.
Orgenesis is led by an executive team with deep expertise in biotechnology, molecular biology, engineering and regulatory affairs. The company’s leadership has guided the expansion of its commercial footprint and the continuous enhancement of its proprietary manufacturing systems. With a mission to democratize access to next-generation therapies, Orgenesis continues to invest in platform innovation, strategic alliances and facility expansions to support the growing global cell and gene therapy industry.
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